Patent Reform, the Remix: Woody Guthrie’s “This Land is Your Land”

Today, CongressDaily’s TechDailyDose Blog broke news that the House Republican High-Tech Working Group wrote a letter to House Speaker Pelosi in support of U.S. Patent Reform. In the letter, the Group, tasked to address  post-internet bubble bust of the IT/telecommunications industry, ask for systemic change in the intellectual property system. Indeed, when the Group was created in 2005, systemic patent reform “especially for one industry” was one of its stated legislative priorities:

“Patent Reform – We will work to modernize the patent system so that companies have incentives to produce new and high-quality patents, and that the United States Patent and Trademark Office (USPTO) provides effective turnaround especially for an industry [emphasis added] that has rapidly changing technology and innovations.”

Note: The U.S. intellectual property system is made of sophisticated laws and regulations that have produced the most innovative country in history, across all industries.

It governs every inventor, small and big alike:

“This ip system is your patent system, this ip system is my ip system
From California to the New York Island
From the Redwood Forest to the Gulf Stream waters
This ip system was made for you and me.

“As I went walking that ribbon of highway
I saw above me that endless skyway
I saw below me that golden valley
This ip system was made for you and me.

“I roamed and I rambled and I followed my footsteps
To the sparkling sands of her diamond deserts
While all around me a voice was sounding
Saying this ip system was made for you and me.

“When the sun came shining, and I was strolling
And the wheat fields waving and the dust clouds rolling
A voice was chanting, As the fog was lifting,
This ip system was made for you and me.

“This ip system is your ip system, this ip system is my ip system
From California to the New York Island
From the Redwood Forest to the Gulf Stream waters
This ip system was made for you and me.”

(Original lyrics at Wikipedia)

A Stimulated NIH Discovers the Devil in the Grant Details

In February, Congress awarded the National Institutes of Health with stimulus funds to the tune of $10.4 billion through the American Recovery and Reinvestment Act of 2009 (Recovery Act). The funding is directed towards helping the United States improve its “scientific infrastructure”: education initiatives, research, “investment in biomedical research and development, public health and health care delivery” (NIH Press Release), including $400 million for comparative effectiveness studies.

Acting National Institutes of Health Director, Raynard S. Kington, MD, has done an excellent job of diversifying the kinds of projects that funding will support, as well as looking for solutions to some of the more, well, I’ll call them opportunities for growth (read: beaurcratic red tape).

Science Magazine further describes these opportunities in the April 17 edition article “NIH Stimulus Plans Triggers Flood of Applications—and Anxiety.”

Grant applicants question whether the NIH has the capacity to manage the tsunami of applications.  Researchers in the Science article also ask if the NIH baseline funding “will grow at anywhere close to the rate needed to handle the blizzard of new ideas and expanded scientific work force” that the Recovery Act funding will produce once the stimulus funds expire. This would allow the projects to continue, if further research was recommended.

Additionally, an April 24 Burrill Report podcast (http://www.burrillreport.com/article-1311.html) interviews Reg Kelly, Director of the California Institute for Quantitative Biosciences (QB3), about whether the stimulus could slow down discoveries. University researchers, seeing state and alumni funding cuts, will spend all of their time preparing grant applications.  Researchers are forced to ignore current projects during the application process. Even if they do receive funding, they will face a technology transfer system that isn’t quite ready for a grand influx of fresh ideas just “waiting” to get picked up for further research & development. Kelly further asks if the technology transfer community is collectively incentivized (and collectively capable) of prioritizing funding for stated NIH priorities like personalized medicine, vaccines (read today: swine flu), cancer, and HIV/AIDS research.

While the stimulus created an “innovation backlog”, it can only be a good thing. For the next two years, NIH programs like “Grand Opportunities” and “Challenge Grants” will enable today’s bright minds to forge new paths into health and environmental sustainability – at least for the next 2 years, when the grant rivers run dry.  In 2012, the new challenge will be utilizing the innovation boomtown the stimulus will have inevitably created. 

If the stimulus succeeds in providing researchers enough funding to help form ideas to improve the world, it will take just as much effort for the biotechnology industry to turn that research into tangible products for a global audience.

Next question: Are the other United States federal agencies (FDA, USDA, and USPTO among them) ready to usher these innovations into the economy?

CAFC Judge Rader: “Strong IP System Allows Countries to Compete in World Marketplace”

I recently discovered an interview series on the intellectual property system on YouTube, produced by CropLife International.  Of particular interest is the interview with U.S. Federal Circuit of Appeals (CAFC)  Judge Randall R. Rader (Watch: http://www.youtube.com/watch?v=tB3OROLi9IM). I liked the way Judge Rader defined intellectual property: a way to protect the “know-how” of any economic entity (company, university, and individual) to do business in today’s global marketplace.

During the interview, Judge Rader focused on a part of the intellectual property system often left assumed by audiences professional, but ignored by audiences general: the importance intellectual property in building a solid economic foundation.  Like currency, without a mutual agreement on how much a dollar is worth — or how valuable a patent is — its hard to fund research or bring a new product to the marketplace.

I visited the United Nations Millenium Goals for further analysis: http://www.un.org/millenniumgoals/.  The goals have a target date of 2015, less than 6 years away. Among the goals were the end of poverty and hunger, maternal as well as children’s health, combatting HIV/AIDS, environmental sustainability, and global partnership. It’s exciting to see countries, one by one, supporting progress on behalf of their citizens.

Its hard to see how strong intellectual property rights can help humanity solve any of these problems — if you don’t know where to look. But if you talk to folks in the know about IP, they can tell you stories:

1. A university researcher whose child was diagnosed with a rare disease, and inspired that same researcher to dedicate his/her life to finding a cure. The researcher discovered an important part of the solution and now works for a biotechnology company, who uses the company’s intellectual property assets to get funding for further research, clinical trials, hoping to bring a product to market to the world and to their child;

2. A country that, after winning their national independence, seeks to build its economy using the traditional knowledge of its indigenous people;

3. A university working with a pharmaceutical company through technology transfer to begin funding research it would have otherwise been unable to afford;

4. A non-profit organization’s CEO, who while working with doctors in an inner-city clinic discovers a faster way to detect (called a diagnostic) early on-set of a disease. The non-profit then uses the knowledge, in an agreement with further funding from universities or companies or government entities, to patent the discovery. The patent eventually helps bring the diagnostic to market.

While no one knows how the struggles meeting our Millenium Goals will be described in 100 years, it is certain that a strong intellectual property system allows every country to provide a chance for its citizens to bring their good idea to the table.

A convergance occurs, then, between our goals for the world and our rights in a strong intellectual property system: a convergance producing solutions and a better world.

Below are two additional interviews on intellectual property within the series worth noting:

Carrie LaCrosse (http://www.youtube.com/watch?v=FCD54T-S1Xg)

Carrie LaCrosse (Office on Intellectual Property Enforcement, US Department of State) discusses the value of IP for agriculture, looking in particular at new plant varieties and how IP is part of the solution in addressing the issues of food security.

Howard Minigh (http://www.youtube.com/watch?v=EZZxke_-bkY)

Howard Minigh (CEO and President of CropLife International) discusses the importance of IP for agricultural production. With the world population increasing, more food will need to be produced on less land. IP rewards innovation, and encourages further investment in solutions that address food security issues in a sustainable manner.

CropLife International is a “global federation representing the plant science industry and a network of regional and national associations in 91 countries… committed to sustainable agriculture through innovative research and technology in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology” (website, here).

BIO to Update Members on Patent Reform, Biosimilars, Court Decisions, and Bayh-Dole Reform

BIO will host a webinar briefing May 8, 2009 (12:30 PM – 2:00 PM EDT) especially for its law firm members.

Attendees will receive updates on patent reform, recent court decisions, biosimilars legislation, Bayh-Dole and licensing/Secretary’s Advisory Committee on Health, Genetics & Society (SACGHS) report.  The briefing dovetails off of BIO’s recent IP Counsels Committee Conference this past March (www.bio.org/ipcc).

The briefing will also include an overview of membership benefits. I’m looking forward to hearing suggestions on how BIO can enhance the work of our 1200+ members.

Are you a member of BIO? Invite your staff to attend using the announcement link at www.bio.org/ip entitled “BIO IP Policy Briefing”

If you’re not a member but want more information on these (and other) issues, why don’t you peruse around www.bio.org/ip?

World IP Day: Special Edition of BIO IP News Weekly

Happy World IP Day!

A special edition of the IP News Weekly focuses on green technology and intellectual property policy. I’ve posted additional resources here:

Judge Randall R. Rader (US Court of Appeals for the Federal Circuit) discusses the value of a strong IP system in maintaining an innovative economy, not only for the ‘industrial giants’ but also for developing nations: http://www.youtube.com/watch?v=tB3OROLi9IM

 

Take a look at the U.S. Chamber of Commerce’s release on World IP Day, too:

“U.S. Chamber Recognizes World IP Day”, April 24, 2009: http://www.theglobalipcenter.com/index.php/news/press-releases/164.

 

World IP Day is Sunday, April 26, 2009. For more information, visit www.wipo.int.

BIO IP News Weekly for April 17, 2009

The IP News Weekly took a break the past couple of weeks, but this week marks my returned coverage. Visit http://www.bio.org/ip/documents/IPNewsWeeklyApril172009.pdf to view the weekly newsletter in PDF form.

To subscribe to the newsletter via email, email me at mnoriega@bio.org.

IP Counsels Committee Conference in Phoenix Discusses Patent Reform

At the latest IP Counsels Committee Conference this past March, Q. Todd Dickinson, Executive Director of the American Intellectual Property Law Association (AIPLA), and E. Anthony Figg of Rothwell, Figg, Ernst & Manbeck, P.C., spoke to BIO’s member companies, universities, and law firm members about patent reform legislation.

Patent Docs‘ Donald Zuhn wrote about Dickinson and Figg on Patent Reform yesterday:

In the three weeks since the panel session took place, Senate Judiciary Committee Chairman Patrick Leahy (D-VT) has managed to get his bill voted out of Committee and placed on the Senate Legislative Calendar. However, as the patent reform debate readies for a move to the House, it is worth reviewing some of issues that were discussed at the IPCC panel session.

Why is it worth reviewing another one of BIO’s substantive conversations on the intellectual property system? This author knows, but you should visit Patent Docs, or call your Congressional representatives, for the details.

Federal Trade Commission holds “Evolving IP Marketplace” hearing on Friday, April 17, 2009

The Federal Trade Commission (FTC) is hosting another meeting in a series entitled “The Evolving IP Marketplace.”  The series of hearings (says the FTC website) will “explore changes in intellectual property law, patent-related business models, and new learning regarding the operation of the IP marketplace since the FTC issued its October 2003 report, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy A Report by the Federal Trade Commission.”

Two panels will discuss “Markets for Intellectual Property” this Friday, April 17. Click here for the April 17 meeting agenda.

The final hearing in Berkeley, CA (May 4 -5 , 2009) will “explore how markets for patents and technology operate in different industries, whether those markets operate efficiently, and how patent policy might be adjusted to respond to problems in those markets in order to better promote innovation and competition.”

Visit http://www.ftc.gov/bc/workshops/ipmarketplace/ to view information and presentations from the entire series.

The Blunders of In Re Kubin

Biotechnology discoveries are made through a complex and lengthy process, often using well-established and validated research methods. But does the routine use of the tools of molecular biology mean that these discoveries aren’t inventions? On April 3, 2009, a U.S. Federal Circuit of Appeals decision (In Re Kubin, read here; read BIO’s amicus filing here) distorts the definition of what a patentable discovery is for the biotechnology industry, but may have a wider impact on all discoveries granted patents in the United States.

The decision logically conflicts with a long history of court decisions, and leaves one asking a simple question: Why?

Researchers pursue discoveries using existing research tools in a process called the scientific method. Researchers hope that by forming a hypothesis, and by testing that hypothesis with tools that have helped previous researchers in their field, their work will eventually lead to a discovery. In all areas of scientific inquiry, the scientific method and research tools are time-tested, reliable, and are not the discoveries themselves. To the U.S. Patent & Trademark Office, the tools and methods are used to make, find, or produce discoveries which are called “patentable inventions.” For example, if you’re a mechanical inventor, and you put together a new machine using known components like screws and bolts in the “prior art” (think of prior art as a master patent database), you can still invent a new, patentable machine. No one would argue that the machine was not new (or “obvious”) because the screws and bolts were already in the prior art. No one would say the new machine (let’s say it combs your hair and reads you romance novels simultaneously) was obvious because other inventors knew how to turn a wrench like you at the time you invented the machine. In other words, no one could correctly claim other inventors would have known to build the same machine just because of the tools or method you used.

In the course of the U.S. Patent & Trademark Office’s existence, the determination of an invention’s improvement over the prior art (called “novelty” and “nonobviousness”) has been made by comparing inventions to previous inventions in its field. Novelty or nonobviousness is not determined by comparing the tools/method used to create the invention to the tools/methods used in the field. At least, not until In Re Kubin. In Re Kubin tells biotechnology inventors that if they work in similar lab setups and use the same starting point, and test their hypotheses the same way with the same lab tools, what they discover is the same thing.

Second, In Re Kubin creates a burden on inventors to show that their invention wasn’t even possible at the time: something was unexpected, something really didn’t go according to plan. But sometimes we discover new things without anything going “wrong”. Biotechnology inventions are often created as a result of using reliable tools/methods in new areas of research to find new discoveries. If taken to its logical conclusion, In Re Kubin would make many biotech inventions that we now think are legitimate inventions obvious because of the used tools or methods in the process of their discovery, and would make it much harder to get a patent for what today are legitimate discoveries and patentable inventions.

Third, we don’t know where Kubin’s reasoning stops. In Kubin, a protein blot on a gel made the later-discovered gene unpatentable because it would have been obvious to any scientist to try routine cloning methods to get to the same result. Sure: “obviously,” many scientists would have wanted to discover that gene, and the tools for doing so apparently existed. But Kubin discovered it first.

Would the Patent Office rather that Kubin hadn’t even tried? What about further discoveries that build upon Kubin’s gene? Are those also unpatentable if they are made with routine research tools and methods? What about a medicine that might one day be developed based on Kubin’s discovery? Is that also just the result of routine experimentation, undeserving of a patent?

Fourth, In Re Kubin may have a damaging impact on information sharing within the scientific community. Inventors will have to protect their tools and methods used in the discovery process. It’s going to stifle information sharing in the scientific community, and will delay solutions yet to be found for today’s health, environmental, and industrial problems.

In Re Kubin is a legal “hindsight” blunder: If an inventor could have guessed (with or without any background knowledge) in a million years that his/her discovery could be made, then it must have been obvious in the prior art at that time.

Hindsight is 20/20… and harmful in determining the patentability of any invention at the time of its discovery.

This post was co-written by Hans Sauer, Associate General Counsel, and Margarita Noriega, Coordinator of IP & Bioethics, at the Biotechnology Industry Organization (BIO).